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FUJIFILM IRVINE SCIENTIFIC, INC.

Last updated May 24, 2026

What FUJIFILM IRVINE SCIENTIFIC, INC. makes

The company produces media and reagents for in vitro fertilization (IVF), including handling and storage solutions like ISolate® and Multipurpose Handling Medium®-Complete, as well as specialized IVD reagents for karyotype suspension testing of amniotic fluid and chorionic villus samples. It also manufactures vitrification carriers and cryotubes for assisted reproduction, alongside thawing and freezing kits for embryo preservation, such as Vit Kit® and Freezing Medium with glycerol. Microtools for assisted reproduction procedures are included in the portfolio.

The portfolio includes Class I and Class II medical devices, regulated under FDA pathways such as 510(k) and UDI compliance. These products are listed in the US regulatory system, with devices authorised for IVF media, diagnostic reagents, and cryopreservation accessories.

Written from this company's registered devices by an AI model, and not verified by a human reviewer.

Information

Country: US
Address: —
Website: irvinesci.com
LinkedIn: —
Facebook: —
Email: [email protected]
Phone: 8004375706
PRRC Contact: —
EUDAMED SRN: —
FDA FEI Number: —
DUNS Number: 057475246

Catalogue (126)

Page 1 of 3

Device	Model / Reference	Registries	Class	Status
ISolate®	99264-12X6mL	FDA UDI	Class II	Active
Multipurpose Handling Medium®-Complete (MHM®-C)	90166-100mL	FDA UDI	Class II	Active
Modified Sperm Washing Medium	9984-12X12mL	FDA UDI	Class II	Unknown
ISolate®	99264-2x100mL	FDA UDI	Class II	Active
Blastocyst Thaw Media Kit	90110-6X10ML	FDA UDI	Class II	Unknown
Chang Amnio	99473-500ML	FDA UDI	Class I	Active
Vit Kit® - Thaw	90137-SO	FDA UDI	Class II	Active
Freezing Medium - TEST Yolk Buffer (TYB) with Glycerol and Gentamicin	90128-100mL	FDA UDI	Class II	Active
Chang Medium B	C100-90ML	FDA UDI	Class I	Active
cryo-GO Vitrification Device	70312-R	FDA UDI	Class II	Active
Vit Kit® - Thaw	90137-DSOC	FDA UDI	Class II	Active
Human Serum Albumin Solution	9988-100mL	FDA UDI	Class II	Unknown
Dextran Serum Supplement	9301-100mL	FDA UDI	Class II	Unknown
ISolate® Stock Solution	99275-12x6ML	FDA UDI	Class II	Active
Vit Kit® - Freeze	90133-SO	FDA UDI	Class II	Active
Polyvinylpyrrolidone (PVP) - Lyophilized	99219-10x1mL	FDA UDI	Class II	Unknown
Modified Sperm Washing Medium	9984-100ML	FDA UDI	Class II	Unknown
cryo-GO Vitrification Device	70310-G	FDA UDI	Class II	Active
Thawing NX - TS	90179-2X20ML	FDA UDI	Class II	Active
Chang Medium MF with Gentamicin	91005-100ML	FDA UDI	Class I	Active
Embryo Freeze Media	90116-6X10ML	FDA UDI	Class II	Unknown
Arctic Sperm Cryopreservation Medium	90170-3x5mL-SK	FDA UDI	Class II	Active
ISolate® Stock Solution	99275-100ML	FDA UDI	Class II	Active
Multipurpose Handling Medium®-Complete (MHM®-C)	90166-500mL	FDA UDI	Class II	Active
Water for Assisted Reproductive Technologies (A.R.T.) Use	9307-1L	FDA UDI	Class II	Active
Chang Medium C	T101-059	FDA UDI	Class I	Active
Chang Medium MF with Gentamicin	91005-500ML	FDA UDI	Class I	Active
cryo-GO Vitrification Device	70311-P	FDA UDI	Class I	Active
Vit Kit® - Thaw	90137-JX	FDA UDI	Class II	Active
Sperm Washing Medium	9983-500mL	FDA UDI	Class II	Active
Sperm Maintenance Medium	99176-12X5ML	FDA UDI	Class II	Unknown
Colcemid Solution	9311-12x10ml	FDA UDI	Class I	Active
MultiBlast Medium®	90139-60mL	FDA UDI	Class II	Unknown
Vit Kit - Freeze NX	90188	FDA UDI	Class II	Active
Serum Substitute Supplement™	99193-100ML	FDA UDI	Class II	Active
Complete Early Cleavage Medium with DSS	90142-2X20mL	FDA UDI	Class II	Unknown
Continuous Single Culture®–NX (CSCM–NX)	90167-20ML	FDA UDI	Class II	Active
Chang Medium in SITU	T104-500ML	FDA UDI	Class I	Active
cryo-GO Vitrification Device	70308-Y	FDA UDI	Class II	Active
7% PVP Solution with HSA	90121-5X0.5mL	FDA UDI	Class II	Active
Human Serum Albumin Solution	9988-12X5mL	FDA UDI	Class II	Active
Chang Medium BMC with Gentamicin	91004-100ML	FDA UDI	Class I	Active
Heavy Oil for Embryo Culture	90189-100mL	FDA UDI	Class II	Active
Multipurpose Handling Medium®-Complete (MHM®-C)	90166-12x12mL	FDA UDI	Class II	Active
ISolate® Concentrate	99306-1L	FDA UDI	Class II	Active
Early Cleavage Medium	90138-60mL	FDA UDI	Class II	Unknown
Colcemid Solution	9311-10ml	FDA UDI	Class I	Active
Chang Medium® C with Gentamicin For Human Amniotic Fluid Cells	99419-500mL	FDA UDI	N/A	Unknown
Complete HTF Medium with SSS™	9922-2X20mL	FDA UDI	Class II	Unknown
Chang Marrow Bone Marrow Culture Medium with Gentamicin	91031-100mL	FDA UDI	Class I	Active

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FDA Recalls (4)

Recalls reported by this firm to the FDA. Listed at company level — FDA recall records don't identify a specific catalogue device.

Fujifilm Irvine Scientific, Inc. has four recall records initiated between September 8, 2021, and November 2, 2023, with statuses listed as either open or classified. The reasons provided include the detection of oil toxicity in Oil for Embryo Culture products, discrepancies in the lower layer component of a sperm separation kit (mismatched lot numbers and expiration dates), and incorrect expiration date labeling on a kit component.

AI-generated summary of the recall records listed below. It describes what the records state and is not an assessment of this manufacturer.

Date	Recall No.	Class	Status	Reason
Nov 2, 2023	Z-0998-2024	—	open, classified	The lower layer component of a sperm separation Kit does not match the certificate of analysis. The kit should contain lower layer (Lot: 0000020686, Shelf Life: 31 December 2024) but incorrectly may contain lower layer (Lot number 9925811106, Shelf Life: 30 November 2023).
Jan 16, 2023	Z-1314-2023	—	open, classified	Due to the detection of oil toxicity in several lots of Oil for Embryo Culture products.
Sep 8, 2021	Z-0248-2022	—	open, classified	Due to a component in kit being labeled with the incorrect Expiration Date
Sep 8, 2021	Z-0249-2022	—	open, classified	Due to a component in kit being labeled with the incorrect Expiration Date